Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical evaluation and measurements of the defect in millimeters
研究概览
简要总结
Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were all healthy and free from any systemic disease;
- •no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study;
- •patients were willing and able to return for multiple follow-up visits;
- •good levels of oral hygiene
排除标准
- •Pregnant and lactating female patients,
- •alcoholics,
- •those receiving any medication that could affect healing of soft or hard tissue
结局指标
主要结局
Clinical evaluation and measurements of the defect in millimeters
时间窗: 9 months
Changes in clinical measurements after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
Radiographic evaluation and measurements of the defect in millimeters
时间窗: 9 months
Changes in bone formation in millimeters after application of simvastatin with and without antimicrobial photodynamic therapy in millimeters
次要结局
未报告次要终点
研究者
Dalia Rasheed Issa
Principle investigator
Kafrelsheikh University